BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS ESTRADIOL II

    MDR report key: 11207650 · Received January 21, 2021

    Report

    Report Number
    8020790-2021-00004
    Event Type
    Malfunction
    Date Received
    January 21, 2021
    Report Date
    March 10, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    CHP
    PMA / PMN Number
    K955647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A BIOMÉRIEUX INTERNAL INVESTIGATION WAS PERFORMED FOLLOWING NOTIFICATION FROM A GERMAN CUSTOMER OF OBTAINING RESULTS WITH VIDAS® ESTRADIOL II REF 30431, LOTS 1008005350 / 210325-0 AND 1008350410 / 210928-0, THAT WERE DISCREPANT WHEN COMPARED WITH ANOTHER METHOD. THE PATIENT WAS RECEIVING HORMONAL THERAPY WITH WELLNARA (JENAPHARM). INVESTIGATION THE INVESTIGATOR REVIEWED THE COMPLAINTS DATABASE FOR SIMILAR REPORTS AGAINST THE LOTS IN QUESTION. NO RECURRENCE OF THIS ANOMALY AGAINST THE LOTS IN QUESTION. REVIEW OF THE BATCH HISTORY AND QUALITY CONTROL RECORDS DID NOT SHOW ANY ANOMALIES DURING THE MANUFACTURING, CONTROL, OR PACKAGING PROCESSES. CONTROL CHART ANALYSIS THE COMPLAINT LABORATORY OBSERVED SIX INTERNAL SAMPLES ON SIX DIFFERENT BATCHES OF VIDAS ESTRADIOL II INCLUDING CUSTOMER'S LOTS. THE CUSTOMER¿S LOTS COMPLIES WITH THE EXPECTED STANDARDS AND IS WITHIN THE TREND OF THE OTHER BATCHES. TESTING THE COMPLAINT LABORATORY TESTED RETAIN KITS FOR VIDAS ESTRADIOL II LOTS 1008005350 / 210325-0 AND 1008350410 / 210928-0 USING THREE INTERNAL SAMPLES AND AN EXTERNAL CONTROL (PROBIOQUAL 20MD11 TARGET 34.24 PG/ML). ALL SAMPLE RESULTS WERE WITHIN THEIR EXPECTED SPECIFICATIONS, AND THERE WAS NO DRIFT OF THE CUSTOMER'S LOTS SINCE THEIR RELEASE. THE CUSTOMER¿S PATIENT SAMPLE WAS NOT AVAILABLE TO SUBMIT TO THE COMPLAINTS LABORATORY FOR FURTHER TESTING. CONCLUSION WITHOUT CUSTOMER'S RETURN SAMPLES, NO FURTHER INVESTIGATION CAN BE PERFORMED TO CONFIRM THE ROOT CAUSE OF THE ISSUE, WHICH MAY BE LINKED TO AN INTERFERENCE REACTION WITH THE HORMONAL TREATMENT TAKEN BY THE PATIENT - WELLNARA (JENAPHARM). WELLNARA (JENAPHARM) IS A PREPARATION FOR HORMONE REPLACEMENT THERAPY (HRT). THE PACKAGE INSERT FOR VIDAS ESTRADIOL II REF 30431 STATES: ¿LIMITATIONS OF THE METHOD - DO NOT USE THE VIDAS® ESTRADIOL II ASSAY TO MEASURE ESTRADIOL LEVELS IN PATIENTS UNDERGOING FULVESTRANT THERAPY. - INTERFERENCE MAY BE ENCOUNTERED WITH CERTAIN SERA CONTAINING ANTIBODIES DIRECTED AGAINST REAGENT COMPONENTS. FOR THIS REASON, ASSAY RESULTS SHOULD BE INTERPRETED TAKING INTO CONSIDERATION THE PATIENT'S HISTORY, AND THE RESULTS OF ANY OTHER TESTS PERFORMED. RESULTS AND INTERPRETATION: ANY CONCENTRATION VALUES OF ESTRADIOL OBTAINED SHOULD BE USED FOR DIAGNOSIS IN ASSOCIATION WITH ADDITIONAL INFORMATION GATHERED BY THE PHYSICIAN (PATIENT QUESTIONING, CURRENT DRUG THERAPY, ULTRASOUND SCAN, CLINICAL OBSERVATIONS, OTHER EXAMINATIONS, ETC.). IN CASES OF ESTROGEN THERAPY, AND PARTICULARLY THAT OF HORMONE REPLACEMENT THERAPY (MENOPAUSE), OVERESTIMATED RESULTS MAY BE OBTAINED.¿ ACCORDING TO THE INVESTIGATION, VIDAS ESTRADIOL II REF (B)(4) LOTS 1008005350 / 210325-0 AND 1008350410 / 210928-0 ARE WITHIN THE EXPECTED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) NOTIFIED BIOMERIEUX THAT THEY OBSERVED A FALSELY OVER-ESTIMATED RESULT FOR A PATIENT WHEN USING VIDAS ESTRADIOL II 60 TESTS (REF 30431, LOT 1008350410, EXPIRY DATE = 28-SEP-2021). THE CUSTOMER OBTAINED THE FOLLOWING RESULT FOR THIS PATIENT WITH VIDAS ESTRADIOL II 60 TESTS, LOT 1008350410: ON (B)(6) 2020: 208.97 PG/ML. IT IS REPORTED THAT THE CALIBRATION PERFORMED ON (B)(6) 2020 WAS VALID. WITH ANOTHER METHOD (NOT SPECIFIED): 36 PG/ML. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED. NOTE: REFERENCE 30431 IS NOT REGISTERED IN THE UNITED STATES. THE U.S SIMILAR DEVICE IS PRODUCT REFERENCE 30431-01 (K955647).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106759 VIDAS ESTRADIOL II VIDAS® ESTRADIOL II CHP BIOMERIEUX SA 1008350410

    Patients

    Seq Age Sex Outcome Treatment
    1